NONE

GUDID B006DCKITS52

NEUROVISION MEDICAL PRODUCTS, INC.

Electromyographic needle electrode, single-use

• Primary Device ID: B006DCKITS52
• NIH Device Record Key: 53365318-5500-4793-afb2-733e3d964720
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NONE
• Version Model Number: NONE
• Company DUNS: 182057401
• Company Name: NEUROVISION MEDICAL PRODUCTS, INC.
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810155860172 [Secondary]
HIBCC	B006DCKITS1 [Unit of Use]
HIBCC	B006DCKITS52 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003745

FDA Product Code

• IKT: Electrode, Needle, Diagnostic Electromyograph

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-11-07
• Device Publish Date: 2016-09-24

On-Brand Devices [NONE]

• B066IJCBFB60: NONE
• B066HGELS102: NONE
• B006PSS7D0: NONE
• B006PSS5D0: NONE
• B006PSS3D0: NONE
• B006PSS26DF52: NONE
• B006PSS13DF52: NONE
• B006PSCS0: NONE
• B006PSCCB0: NONE
• B006NVWGNA102: NONE
• B006NVTKITMSP52: NONE
• B006NVTKITMS52: NONE
• B006NVTKITM52: NONE
• B006NVTKITC852: NONE
• B006NVTKITC752: NONE
• B006NVTKITC652: NONE
• B006NVTKIT600M52: NONE
• B006NVSP102: NONE
• B006NVHANN102: NONE
• B006NVGNA102: NONE
• B006NVFKITNP52: NONE
• B006NVFKIT52: NONE
• B006NV005C1: NONE
• B006NRVMUTINGSENSOR1: NONE
• B006NPFCA52: NONE
• B006NPFC52: NONE
• B006NPDCA52: NONE
• B006NPDC52: NONE
• B006LTE700XS52: NONE
• B006LTE700S52: NONE
• B006LTE700M52: NONE
• B006LTE700L52: NONE
• B006LTE700DCSF52: NONE
• B006LTE700DCS52: NONE
• B006LTE700DCMF52: NONE
• B006LTE700DCM52: NONE
• B006LTE700DCLF52: NONE
• B006LTE700DCL52: NONE
• B006LTE600X5S52: NONE
• B006LTE600X4S52: NONE
• B006LTE600X3S52: NONE
• B006LTE600S52: NONE
• B006LTE600ML52: NONE
• B006LTE600M52: NONE
• B006LTE600L52: NONE
• B006LSE600MSP52: NONE
• B006LSE600M52: NONE
• B006LSE500MSIT52: NONE
• B006LSE500MS52: NONE
• B006LSE500M52: NONE